FDA Device recall Z-2239-2021
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 0088445046…
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 0088445046… by Merit Medical Systems, citing there is a potential that 7F sheaths are packaged as 10F sheaths.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2239-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-30 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | AL, AR, CA, CO, DE, FL, GA, HI, IA, IL, KY, MA, MD, ME, MI, MN, NC, NE, NJ, NV, NY, OH, OR, PA, RI, TX, VA, VT, WI |
Product
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Reason
There is a potential that 7F sheaths are packaged as 10F sheaths.
Identifiers
| code_info | Lot # I2059849 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2239-2021%22
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